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Not yet recruiting NCT07284745

A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism

Phase III Interventional Irritability Associated With Autism Spectrum Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KarXT, KarX-EC, KarXT + KarX-EC Matching Placebo.
Who it may be relevant to
Registry conditions: Irritability Associated With Autism Spectrum Disorder. Basic parameters: 5 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of KarXT + KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder

Overview

The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.

Interventions

  • Drug KarXT
    Specified dose on specified days
  • Drug KarX-EC
    Specified dose on specified days
  • Drug KarXT + KarX-EC Matching Placebo
    Specified dose on specified days

Primary outcome measures

  • Change From Baseline in the Aberrant Behavior Checklist Irritability (ABC-I) Score at Week 8 [Time frame: Week 8]
Secondary outcome measures (12)
  • Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Week 8 [Time frame: Week 8]
  • Number of Participants With ABC-I Response at Week 8 [Time frame: Week 8]
  • Change From Baseline on the ABC Subscale for Social Withdrawal at Week 8 [Time frame: Week 8]
  • Change From Baseline on the Stereotypic Behavior Subscale at Week 8 [Time frame: Week 8]
  • Change From Baseline on the Hyperactivity/Noncompliance Subscale at Week 8 [Time frame: Week 8]
  • Change From Baseline on the Inappropriate Speech Subscale at Week 8 [Time frame: Week 8]
  • Clinical Global Impression-Improvement (CGI-I) Score at Week 8 [Time frame: Week 8]
  • Number of Participants With Procholinergic Symptoms [Time frame: Up to approximately 12 weeks]
  • Number of Participants With Anticholinergic Symptoms [Time frame: Up to approximately 12 weeks]
  • Number of Participants With Treatment-emergent Adverse Events (TEAEs) [Time frame: Up to approximately 12 weeks]
  • Number of Participants With Serious Adverse Events (SAEs) [Time frame: Up to approximately 12 weeks]
  • Number of Participants With Adverse Events of Special Interest (AESIs) [Time frame: Up to approximately 12 weeks]

Eligibility criteria

Inclusion criteria

  • Participants must have a confirmed diagnosis of ASD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the K-SADS-PL and must be experiencing symptoms of irritability.
  • Participants must have ABC-I ≥18 (Irritability subscale of the ABC) and CGIS specific to irritability ≥4, at screening and baseline (Day 1).

Exclusion criteria

  • Participants must not have a current primary DSM-5 diagnosis of bipolar disorder, including bipolar II disorder, schizophrenia, schizoaffective disorder, major depressive episode as determined by clinical instrument, or post-traumatic stress disorder (PTSD).
  • Exception Include: Participants with comorbid ADHD, provided that attention deficit/hyperactivity disorder (ADHD) is not the primary disorder, the participant is adequately treated and based on the investigator judgment the disorder is clinically stable.
  • Participants must not have history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.
  • Participants must not have a risk for suicidal behavior, and any clinically significant abnormal laboratory test.
  • Other protocol-defined Inclusion/Exclusion criteria may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 26 centers
  • Local Institution - 0036 — Dothan
  • Local Institution - 0236 — Phoenix
  • Local Institution - 0031 — Anaheim
  • Local Institution - 0257 — Glendale
  • Local Institution - 0233 — Redlands
  • Local Institution - 0181 — San Rafael
  • Local Institution - 0252 — Colorado Springs
  • Local Institution - 0264 — Boca Raton
  • … and 18 more centers
Canada · 5 centers
  • Local Institution - 0289 — Airdrie
  • Local Institution - 0136 — Edmonton
  • Local Institution - 0135 — Kingston
  • Local Institution - 0205 — Toronto
  • Local Institution - 0187 — Montreal
Australia · 4 centers
  • Local Institution - 0010 — Westmead
  • Local Institution - 0007 — Brisbane
  • Local Institution - 0045 — Melbourne
  • Local Institution - 0286 — Melbourne

Identifiers

NCT: NCT07284745 · CN012-0044 · 2025-523189-26-00 · U1111-1325-4950

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗